FDAnews
www.fdanews.com/articles/188036-moleculight-gains-fdas-de-novo-clearance-for-fluorescent-imaging-device

MolecuLight Gains FDA’s De Novo Clearance for Fluorescent Imaging Device

August 15, 2018

Toronto, Ontario-based devicemaker MolecuLight received the FDA’s De Novo clearance for its handheld fluorescence imaging device, the MolecuLight i:X.

The portable device captures fluorescence information from wounds and surrounding tissue using still images and videos in real-time.

The device, which previously received the CE Mark and Health Canada Medical Device License, allows clinicians working on skin wounds to digitally record images of the wound and images of fluorescence emitted from the wound when exposed to an excitation light.

View today's stories